NCT06449547

Brief Summary

The goal of this observational study is to explore risk factors of anxiety and depression in patients with herpes zoster neuralgia, and the changes of certain serum biomarkers and functional brain magnetic resonance images of these patients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Jun 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jun 2024Dec 2026

First Submitted

Initial submission to the registry

May 19, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

June 21, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

1.9 years

First QC Date

May 19, 2024

Last Update Submit

August 23, 2024

Conditions

Keywords

AnxietyDepressionHerpes ZosterNeuralgia

Outcome Measures

Primary Outcomes (1)

  • HADS score

    Enrolled patients will be first evaluated by Hospital Anxiety and Depression Scare questionaire and according to the HADS score, patients will be divided to group with anxiety/depression and group without anxiety/depression.

    during hospital stay, average of 1 week

Secondary Outcomes (9)

  • Interleukin (IL)-1β plasma level

    during hospital stay, average of 1 week

  • IL-2 receptor plasma level

    during hospital stay, average of 1 week

  • IL-6 plasma level

    during hospital stay, average of 1 week

  • IL-8 plasma level

    during hospital stay, average of 1 week

  • IL-10 plasma level

    during hospital stay, average of 1 week

  • +4 more secondary outcomes

Study Arms (4)

patients with anxiety

Patients in this group suffered from herpes zoster neuralgia and had a score more than or equal to 8 for Hospital Anxiety and Depression Scale- Anxiety questionnaire.

Diagnostic Test: Hospital Anxiety and Depression Scale

patients without anxiety

Patients in this group suffered from herpes zoster neuralgia and had a score less than 8 for Hospital Anxiety and Depression Scale- Anxiety questionnaire.

Diagnostic Test: Hospital Anxiety and Depression Scale

patients with depression

Patients in this group suffered from herpes zoster neuralgia and had a score more than or equal to 8 for Hospital Anxiety and Depression Scale- Depression questionnaire.

Diagnostic Test: Hospital Anxiety and Depression Scale

patients without depression

Patients in this group suffered from herpes zoster neuralgia and had a score less than 8 for Hospital Anxiety and Depression Scale- Depression questionnaire.

Diagnostic Test: Hospital Anxiety and Depression Scale

Interventions

Hospital Anxiety and Depression Scale questionnaire is used to test patients for anxiety and depression.

patients with anxietypatients with depressionpatients without anxietypatients without depression

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study will be conducted in patients who are diagnosed as herpes zoster neuralgia

You may qualify if:

  • Age more than 18 years old
  • Diagnosed as herpes zoster neuralgia
  • Signing informed consent

You may not qualify if:

  • Unable to complete the scale assessment
  • History of mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji hospital

Wuhan, Hubei, 430031, China

RECRUITING

Related Publications (1)

  • Du J, Sun G, Ma H, Xiang P, Guo Y, Deng Y, Li S, Li X. Prevalence and Risk Factors of Anxiety and Depression in Patients with Postherpetic Neuralgia: A Retrospective Study. Dermatology. 2021;237(6):891-895. doi: 10.1159/000512190. Epub 2020 Dec 16.

    PMID: 33326962BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum is obtained to test for biomarkers

MeSH Terms

Conditions

Herpes ZosterAnxiety DisordersDepressionNeuralgia

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsMental DisordersBehavioral SymptomsBehaviorPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yang Shuguang, M.D

    Tongji medical college of Huazhong University of Science and technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei wei, M.D, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy director of anesthesiology

Study Record Dates

First Submitted

May 19, 2024

First Posted

June 10, 2024

Study Start

June 21, 2024

Primary Completion

May 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

no plan to make individual participant data (IPD) available to other researchers

Locations